Low profile gastrointestinal tubes are frequently used for long term tube fed patients who are ambulatory and/or in a combative state and require a smaller, more "manageable" gastrostomy device. These smaller, more manageable devices presently utilize two different types of internal retention bolsters each of which attach to a distal end of the gastrointestinal tube to hold and affix a hollow organ of choice, e.g. the stomach, against the posterior abdominal wall. The hollow organ is so affixed by capturing the organ wall and abdominal wall between an internal retention bolster and an external retention skin disc each of which are attached to opposite ends of a gastrointestinal tube. The gastrointestinal tube is preferably of a short length slightly greater than the combined thicknesses of the abdominal and organ walls. The first type of internal retention bolster of the two types available remains the dominant type on the market and utilizes a deformable obturatable retention bolster to secure the gastrointestinal tube within the organ of choice. The method of using this type of obturatable retention bolster consists of inserting an obturator rod into the lumen of the gastrointestinal tube to abut or engage the distal end of the bolster and mechanically elongate and thereby slenderize the silicone, latex or polyurethane bolster to a size about that of the diameter of the tube. Such slenderization of the bolster allows safe insertion or removal of the tube and bolster into or from an established, matured stoma.
The second type of internal retention bolster utilizes an elastomeric, e.g. silicone, latex, polyurethane, or the like, balloon which is affixed at the distal tip of the gastrointestinal tube. The elastomeric balloon can be inflated and deflated from the proximal, external retention end. The balloon type retention gastrointestinal tubes are often unreliable in nature because the thin membranes of the balloons have a tendency to breakdown if used in a gastric environment. The present invention preferably relates to the first type of low profile gastrostomy device which uses an obturatable retention bolster for affixing the organ of choice.
Obturatable retention bolsters are currently the most common means used to secure low profile skin level gastrointestinal tubes in a matured stoma. However, due to the fact that the tubes are precisely sized to fit the exact depth of the stoma, placement can be both difficult and dangerous. The desirable short length of the skin level gastrointestinal tube makes it very difficult to place. Prior to the present invention, in order to properly place a tube, two fingers had to be placed under the external retention skin disc while pressing the proximal end of the obturator with the thumb. In so doing, the obturator fully obturates and elongates the obturatable retention bolster secured to the distal end of the tube and in communication with the distal end of the obturator. While obturating and elongating the bolster to slenderize the same, the bolster must be pushed into and through the stoma. For proper gastrostomy tube placement, the entire internal retention bolster, obturated to a slenderized configuration, must be completely within an organ such as the stomach prior to deactivating the obturation mechanism. The obturation mechanism is deactivated by withdrawing the obturator to allow the internal retention bolster to assume its preset enlarged shape. However, because the tube length between the distal retention bolster and the external retention skin disc is so closely matched to the thicknesses of the organ and abdominal walls, little extra room remains for manipulation thereof with two or more fingers inserted between the skin and the external skin disc. Thus, a tremendous amount of force must be placed on the tube or catheter and on the patient's abdomen for proper placement. Such a tremendous force is required for placement in order to ensure that the internal retention bolster is completely within the organ prior to deactivating the obturator and allowing the slenderized internal retention bolster to assume its natural enlarged shape.
Since this tube placement procedure is usually performed by "blind" bedside placement without x-ray or endoscopic confirmation, there have been deaths and other serious complications reported where the internal retention bolster was allowed to expand before it was fully within the desired organ. Premature expansion of the retention bolster allows the organ, such as the stomach to separate from the abdomen and in such a case allows nutritional formula, gastric contents and/or air to be delivered into the peritoneum.
The short length of skin level gastrointestinal tubes, which inherently lack space between the internal bolster and the external skin disc for manipulation thereof, has also hindered and sometimes prevented clinicians from using the obturator to re-slenderize the bolster prior to removal of the tube. In such a situation, forceful traction has been utilized to forcefully overcome the resistance of the internal bolster to deform the bolster as it is forced through the stoma to remove the catheter from the patient. Forcefully pulling out a gastrointestinal tube with traction rather than by means of re-obturation with this type of large internal retention bolster is both painful and damaging to the integrity of the matured stoma site.
A method and apparatus that would facilitate obturation of the gastrointestinal-type tube for more reliable insertion and removal thereof would be desirous. Such a device would serve to decrease stress on the stoma, decrease pain experienced by the patient upon removal of the tube, and help prevent leakage of fluids such as stomach acids from around the stoma which result from improper placement of the gastrostomy device upon insertion.